Subcutaneous Semaglutide in Systemic Scleroderma

NCT ID: NCT06149260

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2024-12-31

Brief Summary

This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis

Detailed Description

Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the cardiac, pulmonary, and gastrointestinal systems. This is a small prospective and open-label clinical trial of semaglutide in adults with systemic slceorsis. 10 systemic sclerosis patients will be recruited and receive semaglutide for 24 weeks. The primary endpoint of the study is the change in mRSS at 24 weeks of treatment.

Conditions

Scleroderma, Systemic; Fibrosis; Semaglutide

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Semaglutide

Participants will receive once-weekly semaglutide subcutaneous injection at escalating doses from 0.25 mg/week to 0.5 mg/week.

Group Type: EXPERIMENTAL

Semaglutide Pen Injector

Intervention Type: DRUG

Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and then maintained 0.5mg until the end of treatment in total 24 weeks.

Interventions

Semaglutide Pen Injector

Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and then maintained 0.5mg until the end of treatment in total 24 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Gender unlimited;

2. Age 18-65 years old (including 65 years old);

3. Patients diagnosed with SSc who meet the 2013 European Union Against Rheumatology (EULAR)/American Society of Rheumatology (ACR) SSc diagnostic classification criteria and exclude infections, tumors, and other connective tissue diseases.

4. Has received one or more of the following standard systemic treatments allowed by the research protocol:

1. Before the first subcutaneous injection of the study, oral corticosteroids (prednisone not exceeding 15mg/d or equivalent) were administered for ≥ 8 weeks, and stabilizers were administered for ≥ 4 weeks.

2. Before the first subcutaneous injection of the study, patients were treated with Tofacitinib (5-10mg/d) for ≥ 8 weeks and received a stabilizer dose for ≥ 6 weeks.

3. If one or more of the following immune modulators are used, treatment must be given for ≥ 12 weeks before the start of the study, and treatment with a stabilizer dose must be given for ≥ 6 weeks Oral mycophenolate mofetil (MMF) ≤ 1.5 g/day Methotrexate (MTX) oral ≤ 15 mg/week, combined with folic acid Cyclosporine If the subjects use ≥ 2 of the above immunomodulatory drugs in combination, the appropriateness of the subjects' participation in the study must be discussed with the medical supervisor and study chair before enrollment.

5. A modified Rodnan Skin Score (mRSS) of > 14

6. Those who sign an informed consent form, voluntarily participate in this project, and are able to complete follow-up as required.

Exclusion Criteria

1. Prior to the first dose, Body Mass Index (BMI) < 18.5 kg/m2; weight loss of 10% within one month or 20% within six months.

2. Family or personal history of type 2 multiple endocrine neoplasia or medullary thyroid carcinoma, with family history involving first-degree relatives.

3. History of malignant tumors or a history of malignant tumors within the past 5 years before screening.

4. Presence of other inflammatory diseases that may interfere with efficacy assessment, including but not limited to rheumatoid arthritis (RA), overlap syndrome, psoriasis, dermatomyositis, multiple sclerosis, Crohn's disease, or active Lyme disease.

5. Severe gastrointestinal complications of systemic sclerosis (SSc), such as significant swallowing difficulties, and severe diseases affecting vital organ systems such as the heart, brain, lungs, liver, kidneys, or blood, as deemed unsuitable for participation in the study by the investigator.

6. Known current active or recurrent severe infections, including active tuberculosis.

7. Congenital immunodeficiency or congenital immunosuppression.

8. Substance abuse, alcoholism, or psychiatric disorders, rendering patients uncooperative or unable to adhere to treatment; poor predictability of compliance.

9. Women who are pregnant, breastfeeding, or planning to become pregnant.

10. Patients currently participating in other clinical trials.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Rong Xiao

Professor of Dermatology, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rong Xiao, MD

Role: STUDY_CHAIR

Department of Dermatology, Second Xiangya Hospital of Central South University, Changsha, China

Licong Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Yaqian Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Zhuotong Zeng, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Zhan Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Xiangning Qiu, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Ruixuan Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Yi Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Ke Chai, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Hao Ren, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Yangfan Xiao, MD

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital

Locations

the Second Xiangya Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rong Xiao, MD

Role: CONTACT

xiaorong65@csu.edu.cn

13808425555

Licong Liu, MD

Role: CONTACT

Liulicong1997@csu.edu.cn

18573185298

Facility Contacts

Rong Xiao, MD

Role: primary

xiaorong65@csu.edu.cn

+8618573185298

Other Identifiers

LYG2022061

Identifier Type: -

Identifier Source: org_study_id